Cleared Traditional

K811936 - CHEMICAL AUTOCLAVE INDICATOR TAPE

K811936 is the FDA 510(k) clearance for CHEMICAL AUTOCLAVE INDICATOR TAPE by American Hospital Supply Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811936 · American Hospital Supply Corp. · General Hospital
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Jul 1981
Decision
22d
Days
Class 2
Risk

K811936 is an FDA 510(k) clearance for the CHEMICAL AUTOCLAVE INDICATOR TAPE. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Hospital Supply Corp. devices

Submission Details

510(k) Number K811936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date July 28, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 99
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K811936.
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989
3M STEAM STERILIZATION INDICATOR
K801057 · 3M Company · Jun 1980
STERILIZATION PROCESS/ MAYO PAD
K792624 · Procter & Gamble Mfg. Co. · Jan 1980